PTT-121: a first‑in‑humans safety study in healthy adults
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PTT-121 After Single and Multiple Ascending Doses in Healthy Chinese Subjects
Run by Pyrotech Therapeutics, Inc. · NCT07768176 · Data updated 2026-11-12
Researchers will test PTT-121 in healthy Chinese adults to see if it is safe and well tolerated and to understand how the body handles the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Pyrotech Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | August 18, 2026 |
| Main results expected | August 31, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07768176 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults 18–55 years old with BMI 18.0–26.0, and no significant medical conditions as determined by the investigator.
✕Probably not a fit
Individuals with significant uncontrolled medical conditions or known hypersensitivity to PTT‑121 or its components may not benefit and could be excluded for safety.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, single‑center, randomized, double‑blind, placebo‑controlled study evaluating the safety, tolerability, and pharmacokinetics of intravenously administered PTT‑121 in healthy adults aged 18 to 55. The trial includes both single ascending dose (SAD) and multiple ascending dose (MAD) aspects to determine safe dosing ranges. Participants are assigned to PTT‑121 or placebo and monitored for adverse effects and blood drug levels. The study is sponsored by Pyrotech Therapeutics, with the Pearl investigator site at Peking University Third Hospital in Beijing. Enrollment focuses on healthy volunteers who meet specific health criteria and exclusions for significant medical history or drug hypersensitivity.
Why it matters
Potential benefit: If successful, the study could help determine a safe dose range for PTT‑121 and inform future research in patients who might benefit from this therapy.
How similar studies have gone: Phase 1 trials of similar biologic or investigational agents have shown that early safety and PK testing in healthy volunteers can inform dosing for later studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adults aged between 18 and 55 years. * BMI 18.0-26.0. * Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc. Exclusion Criteria: * History of any clinically significant disease or disorder of the cardiovascular, respiratory, gastrointestinal, genitourinary, hematologic/lymphatic, neurologic, reproductive, psychiatric, endocrine, immunologic, musculoskeletal, breast, ear, ocular, thyroid, neoplastic, metabolic, or dermatologic systems, as determined by the Investigator. * History of hypersensitivity to the active ingredient of the investigational product, any of its excipients, or related compounds; or a history of severe drug-induced allergic reactions, including but not limited to angioedema and bronchospasm/asthma.
Where it's running
-
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Ran Wei
- Email: ran.wei@pyrotech.com
- Phone: +86 10 81938094
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.