A Phase 1/2a Study of Safety, Pharmacokinetics and Neutralizing Activity of SPK002 as pre-exposure prophylaxis of COVID-19 in healthy volunteers (Phase 1) and immunocompromised individuals (Phase 2a).
Phase 1
Active, not recruiting
- Conditions
- Immunocompromised individuals (phase 2a), Healthy volunteers (Phase 1)MedDRA version: 23.0Level: PTClassification code: 10084458Term: COVID-19 prophylaxis Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- CTIS2023-505279-62-00
- Lead Sponsor
- Spikimm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method