drugset / Trial / NCT06557785
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
Phase 1
Active not recruiting
53 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Department of Health and Human Services · collabNational Institutes of Health (NIH) · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are: 1. the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors, 2. the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and 3. these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.
Timeline
- Start
- 2024-11-25
- Primary completion
- 2027-03-09
- Completion
- 2027-03-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CH505 TF mRNA-gp160 | Messenger RNA (mRNA) | 25 ug | Intramuscular |
| Subject | CH505 TF mRNA-gp160 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | CH505 TF mRNA-gp160 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | CH505 TF mRNA-gp160 | Messenger RNA (mRNA) | 150 ug | Intramuscular |
| Subject | CH505M5 N197D mRNA-gp160 | Messenger RNA (mRNA) | 25 ug | Intramuscular |
| Subject | CH505M5 N197D mRNA-gp160 | Messenger RNA (mRNA) | 50 ug | Intramuscular |
| Subject | CH505M5 N197D mRNA-gp160 | Messenger RNA (mRNA) | 100 ug | Intramuscular |
| Subject | CH505M5 N197D mRNA-gp160 | Messenger RNA (mRNA) | 150 ug | Intramuscular |