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NCT06127498
The Safety and Tolerability of A8G6 COVID-19 Neutralization Antibody Combined With Nasal Spray
NA trial testing A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray in SARS-CoV-2 in 108 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | The Second Affiliated Hospital of Chongqing Medical University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 May 2022 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- A8G6 SARS-CoV-2 Neutralization Antibody combination nasal spray — full drug profile →
- A8G6 SARS-CoV-2 Neutralization Antibody nasal excipient
Conditions studied
- SARS-CoV-2 — all drugs for SARS-CoV-2 →
- Prevention — all drugs for Prevention →
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Who can join
Adults 18 to 65, any sex, with SARS-CoV-2 or Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, placebo-parallel intervention clinical study that will include approximately 108 healthy subjects based on inclusion and exclusion criteria. Patients meeting inclusion and exclusion criteria were randomly assigned to one of four different cohorts. Subjects in each cohort were randomly assigned 5:1 to two parallel administration groups, one of which served as a control. Each cohort was given either the experimental drug or placebo by nasal spray at different doses and intervals, and blood was collected on an empty stomach before the first dose. Right nostril and nasal swabs were collected for immunotoxicity, immunogenicity (immunogenicity collection and detection in cohorts 3 and 4 only), and drug concentration detection. Subjects in the first three cohort were required to return to the study Center 3±1 days after the last dose for blood samples, bilateral nostril and nasal swabs for drug concentration, immunotoxicity, physical examination, vital signs, and safety laboratory indicators (blood routine, blood biochemical, and urine routine). Subjects in cohort 4 returned to the study center 7±2 days after the last dose. To evaluate the safety and tolerability of A8G6 COVID-19 neutralization and antibody combined nasal spray in healthy subjects by comparing the test results of subjects in different cohorts, and to study its concentration in serum and nasal swabs in healthy subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06127498
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06127498 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Affiliated Hospital of Chongqing Medical University
- Last refreshed: 13 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06127498.
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