Trials / Completed
CompletedNCT04629131
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TNM002 in Healthy Adults
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Intramuscular Administration of a Single Dose of TNM002 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics properties of TNM002 following a single intramuscular dose in healthy adult subjects.
Detailed description
The study a randomized, double-blinded, placebo-controlled, dose-escalation phase I trial. A total of 32 healthy adult subjects will be enrolled into 4 cohorts sequentially. Each participant will receive a single IM dose of TNM002 or placebo according to the cohort in which they were enrolled. After injection (Day 1), participants remain in the study site for observation up to 5 days. Following completion of the safety assessments and sampling for PK/PD analyses on Day 4, participants will be discharged from the study site. On Day 8, 15, 29, 43, 64 and 85, participants will return for safety assessments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TNM002 Dosage 1 (10 μg/kg) | TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once. |
| BIOLOGICAL | Placebo | placebo to match TNM002 Dosage 1, given once |
| BIOLOGICAL | TNM002 Dosage 2 (35 μg/kg) | TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once |
| BIOLOGICAL | Placebo | placebo to match TNM002 Dosage 2, given once |
| BIOLOGICAL | TNM002 Dosage 3 (100 μg/kg) | TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once |
| BIOLOGICAL | Placebo | placebo to match TNM002 Dosage 3, given once |
| BIOLOGICAL | TNM002 Dosage 4 (250 μg/kg) | TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once |
| BIOLOGICAL | Placebo | placebo to match TNM002 Dosage 4, given once |
Timeline
- Start date
- 2020-11-25
- Primary completion
- 2021-08-13
- Completion
- 2021-08-13
- First posted
- 2020-11-16
- Last updated
- 2022-11-07
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04629131. Inclusion in this directory is not an endorsement.