Can meal timing boost a new oral Drug's potential?
NCT ID NCT07787611
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This Phase 1 trial in healthy Chinese adults aims to assess the safety and tolerability of an experimental oral drug, MWN109, and how well the body absorbs it. Researchers will also explore whether taking the tablet with or without food changes its effects. The study involves single and multiple doses, with participants monitored for side effects and drug levels in the blood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MWN109 tablet
- What this could lead to
- If successful, this early trial could pave the way for larger studies of MWN109, potentially leading to a new oral medication for conditions like metabolic disorders.
- What could go wrong
- This is a small, early-phase safety study in healthy volunteers, so it cannot yet determine if MWN109 works for any disease. The drug may prove unsafe or ineffective in later trials.
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
-
98 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Dec 2025
- 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 50 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. Male or female participants aged 18 to 50 years (inclusive at the time of signing the informed consent form). 2. Body mass index (BMI) = weight (kg) / height squared (m²): SAD part: 19.0 to 29.9 kg/m² (inclusive), with body weight ≥ 55 kg (male) or ≥ 50 kg (female); MAD part: 24.0 to 37.5 kg/m² (inclusive), with body weight ≥ 70 kg (male) or ≥ 60 kg (female). 3. Resting heart rate/pulse ≥ 55 beats/min and ≤ 90 beats/min at screening and before randomization. Exclusion Criteria: 1. History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 tablets), severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis), or a severe allergic constitution. 2. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury, or other high-risk factors that may lead to pancreatitis, or amylase or lipase \> 1.5 times the upper limit of normal (ULN) at screening. 3. Family history or history of medullary thyroid carcinoma; history of thyroid insufficiency or abnormal thyroid hormone levels. 4. Gastrointestinal diseases present at screening that may increase participant risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction) or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months). 5. History of infectious disease within 4 weeks prior to screening (which, in the investigator's judgment, may significantly affect the safety evaluation of the participant), or severe trauma or major surgery within 3 months. 6. History of severe arrhythmia prior to screening judged by the investigator as unsuitable for participation in this study. 7. Any of the following abnormal laboratory findings at screening: a) fasting blood glucose ≥ 7.0 mmol/L or \< 3.9 mmol/L, or HbA1c \> 6.5%; b) estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m²; c) triglycerides (TG) ≥ 5.65 mmol/L. 8. Blood donation, significant blood loss (\> 400 mL), or receipt of blood transfusion within 3 months prior to screening.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Comparative effects of three breathing techniques on heart rate variability, attention, reaction time, and anxiety in healthy adults: a randomized controlled trial
- An Open-Label phase 1 study to assess the safety, tolerability, and pharmacokinetics of a single dose of a new tablet formulation of TRTL-729 in healthy adults
- A phase 2b, randomized, placebo-controlled, observer-blind study in adults 60 years of age and older to evaluate the efficacy, safety, and immunogenicity of a bivalent protein vaccine candidate against respiratory syncytial virus (RSV) and human metapneumovirus (HMPV)
- THERMOS-LUNCH: effects of meals differing in nutritional quality and environmental footprint on postprandial metabolism, Diet-Induced thermogenesis, respiratory quotient, satiety, and hydration status in healthy young men
- Phase i clinical study, open-label, randomized, parallel to evaluate the safety of the 200 mg dexibuprofen following single and multiple dose oral administration in healthy participants of both sexes under fasting and fed conditions.
- Can a copycat humira match the original?