New drug DD-S052P tested in humans for first time
NCT ID NCT07347223
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tested the safety and tolerability of a new drug called DD-S052P in 64 healthy adults. Participants received either the drug or a placebo as an intravenous infusion, in single or multiple doses. The study monitored side effects, vital signs, and lab results to see how the body handles the drug. Results will help decide if further testing is warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DD-S052P
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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64 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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May 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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. Healthy male/female aged to 18-50 years inclusive at the screening visit 2. Must agree to adhere to the contraception requirements: 1. Female must be of non-childbearing potential, defined as meeting at least one of the following: * hysteroscopic sterilization * bilateral tubal ligation or bilateral salpingectomy * hysterectomy * bilateral oophorectomy * be postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Female of childbearing potential who are sexually active must agree to use at least one highly effective method of contraception starting from the 1 month prior to first administration of the study drug until 4 months post-dosing: * Hormonal methods: oral, transdermal, systemic, or implantable contraceptives * Intrauterine devices (IUDs) * Barrier methods: condoms or diaphragms used with spermicide * Surgical sterilization of the male partner 3. Male must use of condom by the male subject plus an effective method of contraception for the subject partner of childbearing potential from study drug administration until 4 months post-dosing (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm, surgical sterilization, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle) 3. Male subjects must not donate sperm from the first dosing until 90 days after the last dosing 4. Non-smoker subject or smoker of not more than 5 cigarettes a day 5. Body Mass Index (BMI) between 18.5 and 32.0 (kg/m2) inclusive, with body weight between 60 and 100 kg inclusive, at Screening and Day -1 6. Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination) 7. Normal Blood Pressure (BP) and Heart Rate (HR) at the screening visit after 10 min in supine position: * 95 mmHg ≤ Systolic Blood Pressure (SBP) ≤ 140 mmHg, * 50 mmHg ≤ Diastolic Blood Pressure (DBP) ≤ 90 mmHg, * 50 bpm ≤ HR ≤ 90 bpm, * Or considered not clinically significant (NCS) by investigators; 8. Normal ECG recording on a 12-lead ECG at the screening visit: * 120 \< PR \< 210 ms, * QRS \< 120 ms, * QTcF ≤ 430 ms for male and QTcF ≤ 450 ms for female * No sign of any trouble of sinusal automatism, * Or considered NCS by investigators 9. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non-relevant by the Investigator 10. Normal dietary habits 11. Signing a written informed consent prior to participation 12. Subject with estimated Glomerular Filtration Rate (eGFR) ≥ 80 mL/min/1.73 m2, as estimated using CKD-EPI creatinine Equation (2021) Exclusion Criteria: 1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, infectious disease; endocrine, immunologic, dermatologic or/and any relevant disease 2. Subject with proteinuria, Grade 2 or higher (CTCAE, Ver.5.0) 3. Symptomatic hypotension whatever the decrease of the blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within 2 min of changing from supine to standing position 4. Positive urine drug testing or alcohol testing at Screening or Day -1 5. Positive Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests 6. Clinical symptoms suspected of acute infectious disease within 2 weeks before the first study drug administration 7. Any medication intake (except acetaminophen) within 1 month or within 5 times the elimination half-life of the medication (whichever is longer) prior to the first administration of study drug 8. Serious or severe adverse reaction, including hypersensitivity, anaphylaxis or hepatotoxicity to carbapenems, cephalosporins, penicillins, polyethylene glycol derivatives, monobactams or any other medication 9. History of hypersensitivity to Ringer solution 10. Blood donation (including as part of a clinical trial) within 2 months before administration 11. General anaesthesia within 3 months before administration 12. Inability to abstain from intense muscular effort 13. Subjects who cannot be reliably contacted in case of an emergency 14. Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses/day) 15. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem or poor mental development 16. Persons deprived of their liberty by judicial or administrative decision; persons under coercive psychiatric care; adults under legal protection (guardianship/trusteeship); persons under court protection 17. Participation in any interventional study within 60 days or within 5 times the elimination half-life of the interventional study drug (whichever is longer) before study check-in 18. Pregnant or breastfeeding or intended to become pregnant during the study 19. Any other reasons identified by the investigator that would preclude the subject's participation in the study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HLB Science
Seoul, Seoul, 05836, South Korea
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