Can a new pill ACC017 be safely dosed? a trial seeks answers
NCT ID NCT06278389
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This early-stage trial is testing an experimental drug called ACC017 in healthy adults to see if it is safe and how the body processes it. Researchers are giving different single doses to small groups of volunteers, some receiving a placebo, to find a recommended dose for future studies. The trial also checks whether taking the drug with food changes its effects and whether it interacts with another HIV medication, emtricitabine/tenofovir alafenamide. The goal is to gather essential safety and dosing information before moving to larger trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ACC017 tablets, an experimental drug, tested alone and with emtricitabine/tenofovir alafenamide (Descovy)
- What this could lead to
- If successful, this trial could determine a safe dose of ACC017 for future studies, potentially leading to a new treatment option for conditions like HIV.
- What could go wrong
- This is an early-phase trial in a small group of healthy volunteers, so results may not predict effects in patients. Side effects are possible, and the drug may not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
May 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Volunteering to sign the informed consent and able to follow protocol-defined procedural requirements; 2. Aged 18 to 55 years (inclusive); 3. Male weighing ≥ 50.0 kg, female weighing ≥ 45.0 kg, and body mass index (BMI) = weight(kg)/height\^2 (m\^2) within the range of 18.5\~26 kg/m\^2 (inclusive); 4. Women of child-bearing potential (WOCBP) or men without a birth plan (including sperm or egg donation) and agreeing to use effective contraception (including one or more non-pharmacological contraceptives or non-heterosexual sexual activity in daily life) from 1 month prior to informed consent up to 3 months after the last dose of the study medication; 5. No history of significant medical or surgical illness, and normal results on vital signs, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, chest X-ray and abdominal ultrasound examination during the screening period, or minor deviations from normal reference values that are not clinically significant in the judgment of the investigator. Exclusion Criteria: 1. Occurrence or persistence of clinically significant abnormal conditions, including but not limited to cardiovascular, respiratory, gastrointestinal (any history of gastrointestinal disorders affecting the absorption of medications), urinary, hematologic and lymphatic, endocrine, musculoskeletal, immune, and neuropsychiatric disorders; 2. Possible or definite allergic reaction to the study drug, placebo, or any of the excipients contained, as judged by the investigator, or allergy (multiple drug and food sensitivities), or a history of allergic disease (e.g., asthma, urticaria, and eczematous dermatitis, etc.); 3. Acute illness, such as respiratory tract infections requiring antibiotic treatment, occurring from screening until study drug administration; 4. Inability to tolerate venipuncture, or history of needle-sickness or blood-sickness, or blood donation including component blood or significant blood loss (≥400 mL) or receipt of blood transfusion within 3 months prior to screening, or planning to donate blood during the trial period; 5. Dysphagia, or surgery within 6 months prior to screening, or surgery planned during the trial, or surgery that interferes with the absorption, distribution, metabolism, or excretion of the medication; 6. Smoking an average of \>5 cigarettes per day within 3 months prior to screening, or inability to stop using any tobacco-based product during the trial period; 7. Average weekly alcohol consumption greater than 14 units (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of 40% (alcohol by volume) spirits, or 150 mL of wine) within 3 months prior to screening or inability to discontinue use of any alcohol-containing product during the trial period, or with a positive breath test for alcohol at screening; 8. Excessive consumption of tea, coffee, and/or caffeinated beverages (more than 8 cups on average per day, 1 cup ≈ 250 mL) within 3 months prior to screening, or inability to stop consuming tea, coffee, and/or caffeinated beverages during the trial period; 9. Consumption or drinking of dragon fruit, mango, grapefruit, popcorn, or foods or beverages prepared from the aforementioned fruits, or foods or beverages containing xanthines, caffeine, or alcohol (including chocolate, tea, coffee, cola, and cocoa), or any other special diet that interferes with the absorption, distribution, metabolism, or excretion of the drug, within 48 hours prior to administration of the study medication; 10. With special dietary requirements, or cannot accept a uniform diet; 11. Use of strong or moderate CYP3A inhibitors (e.g., clarithromycin, telithromycin, ketoconazole, itraconazole and nefazodone, etc.) or strong CYP3A4 inducers (e.g., rifampicin, efavirenz, carbamazepine, phenobarbital, phenytoin, pioglitazone, St. John's wort, and glucocorticoids, etc.) within 28 days or 5 half-lives (whichever is longer) before screening; 12. Use of strong or moderate UGT1A inhibitors (e.g., silybin, ritonavir, atazanavir, quinidine, diclofenac, mycophenolic acid, and osimertinib, etc.) or strong UGT1A1 inducers (e.g., rifampicin, carbamazepine, phenobarbital, and phenytoin, etc.) within 28 days or 5 drug half-lives (whichever is longer) before screening; 13. Use of any prescription drugs, over-the-counter drugs or Chinese (herbal) medicines within 14 days or 5 drug half-lives (whichever is longer) prior to screening; 14. Vaccination (e.g., SARS-CoV-2 virus vaccine, and hepatitis B virus vaccine, etc.) within 1 month before screening, and are not suitable for enrollment as assessed by the investigator; 15. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody, or Tponema pallidum (Tp) antibody at screening; 16. History of substance abuse within 5 years prior to screening, or positive urine drug screen at screening; 17. Females who are pregnant or lactating at the time of screening, or have a positive blood pregnancy test (for WOCBP only); 18. Participation in any interventional clinical trials, including drugs, vaccines, or devices, etc., within 3 months prior to screening,; 19. It is not suitable for a participant to participate in this trial in the judgment of the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy adult participants are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Beijing Ditan Hospital Capital Medical University
Beijing, 100015, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Nicotine pouches put to the test: can they match the cigarette experience?
- Can a neck device dial down pain by zapping the vagus nerve?
- Tight calves may dull the Sole's sense of touch
- Can a migraine pill sway the Body's balance reflex?
- Can an experimental drug share the Body's chemical highways without causing a pileup?
- Can dirty city air speed up the Body's aging clock?