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NCT06158737
A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Phase 1 trial testing JS010 injection in Migraine in 48 participants. Status unknown.
29 June 2024
Quick facts
| Lead sponsor | Shanghai Junshi Bioscience Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 9 May 2023 |
| Primary completion | 29 June 2024 |
| Estimated completion | 21 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- JS010 injection — full drug profile →
- Placebo
Conditions studied
- Migraine — all drugs for Migraine →
Sponsor
Shanghai Junshi Bioscience Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects will be enrolled in the experiment, 8 in each group.They will be randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06158737
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Junshi Bioscience Co., Ltd. trials
Trials by the same sponsor.
- NCT07503756 — JS212 Combination Therapies in Metastatic Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07480733 — Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting
- NCT07484724 — A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Ce · Phase 2 · not yet recruiting
- NCT07518160 — JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study · Phase 2 · not yet recruiting
- NCT07309276 — A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer · Phase 2 · not yet recruiting
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 NCT06158737 (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 Shanghai Junshi Bioscience Co., Ltd.
- Last refreshed: 6 December 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/NCT06158737.
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