VH-2025-0017
Approved Approved 14 Jan 2026 · expires 14 Jan 2027 · Committee A Start amendmentSafety reportSerious breachProgress reportNCR-ASTH-003 · A Phase 1a/1b Study of an Inhaled Biologic in Healthy Volunteers and Adults with Mild Asthma · PI Dr Priya Raman · Northside Clinical Research Unit
Submissions under this recordEach sub-form has its own ID, review and letter; the expiry date never moves
| Form | Submitted | Meeting | Status | Decision | Feedback | Letter |
|---|---|---|---|---|---|---|
| New study VH-2025-0017 | 13 Nov 2025 | 3 Dec 2025 | Approved | 14 Jan 2026 | 3 cycles | Approval letter |
| Amendment 1 · PI CV and indemnity update VH-2025-0017-A-1 | 2 Feb 2026 | 4 Feb 2026 | Approved | 3 Feb 2026 | — | Approval letter |
| Amendment 2 · Protocol v3.0, PICF v3.0 VH-2025-0017-A-2 | 25 Mar 2026 | 25 Mar 2026 | Approved | 23 Apr 2026 | 1 cycle | Approval letter |
| Amendment 3 · Advertising set v2 VH-2025-0017-A-3 | 26 May 2026 | 27 May 2026 | Approved | 2 Jun 2026 | — | Approval letter |
| Serious breach 1 · identifier in free-text AE field VH-2025-0017-PVR-1 | 22 Jun 2026 | 24 Jun 2026 | Acknowledged | 7 Jul 2026 | 1 cycle | Acknowledgment |
| Safety report 1 VH-2025-0017-AER-1 · withdrawn by applicant 28 Aug | — | — | Withdrawn | — | — | — |
| Amendment 4 · Protocol v6.0, change of PI VH-2025-0017-A-4 | 10 Sep 2026 | 11 Nov 2026 | Under review | — | 1 cycle open | — |
Event log
10 Sep 2026
Amendment 4 submitted by Sam Okafor · v1, 9 documents
✉ Amendment submitted: VH-2025-0017-A-4 · to Raman, Okafor, Park
10 Sep 2026
18 Sep 2026
Amendment 4 resubmitted by Dr Priya Raman · v2, 12 documents, change summary attached
21 Sep 2026
28 Sep 2026
Comments sent, cycle 1 3 comments, 2 need a response · due 28 Mar 2027
7 Jul 2026
Serious breach 1 acknowledged Committee A
22 Jun 2026
Serious breach 1 submitted by Dr Priya Raman · sponsor informed 9 Jun
2 Jun 2026
Amendment 3 approved Committee A · expedited
3 Feb 2026
Approval letter regenerated one omitted document added; approval date unchanged
14 Jan 2026
Approved Committee A · full board · period 14 Jan 2026 to 14 Jan 2027
7 Jan 2026
Contingent approval pending signed indemnity
17 Dec 2025
Responses sent, cycle 3 by Dr Priya Raman · 1 of 1 answered, PICF v2.1 attached
10 Dec 2025
Responses sent, cycle 2 1 of 1 answered · original documents re-attached
10 Dec 2025
Responses sent, cycle 1 25 of 25 answered · Protocol v2.0, PICF v2.0, IB v2.0, COI plan v2.0 attached
5 Dec 2025
Comments sent, cycle 1 25 comments, all need a response · due 5 Jun 2026
3 Dec 2025
Reviewed at meeting Committee A
20 Nov 2025
Assigned Committee A · meeting 3 Dec 2025 · reviewers assigned 21 Nov
13 Nov 2025
Submitted by Dr Priya Raman · v1, 11 documents · fee paid
✉ New application submitted: VH-2025-0017 · to Raman, Okafor, Park
13 Nov 2025
Created by Sam Okafor