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NCT04161547
Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers
Phase 1 trial testing CSPCHA115 100 mg; Matching placebo 100 mg in Asthma; Allergic Rhinitis in 40 participants. Completed in 1 June 2020.
1 June 2020
Quick facts
| Lead sponsor | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 12 December 2019 |
| Primary completion | 1 June 2020 |
| Estimated completion | 1 June 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- CSPCHA115 100 mg; Matching placebo 100 mg — full drug profile →
- CSPCHA115 200 mg; Matching placebo 200 mg — full drug profile →
- CSPCHA115 400 mg; Matching placebo 400 mg — full drug profile →
- CSPCHA115 600 mg; Matching placebo 600 mg — full drug profile →
Conditions studied
- Asthma; Allergic Rhinitis — all drugs for Asthma; Allergic Rhinitis →
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd. — full company profile →
Who can join
Adults 18 to 45, any sex, with Asthma; Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy volunteers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The randomized, single- and multiple- ascending dose studies of the safety, tolerability, pharmacokinetics of CSPCHA115 in healthy Chinese subjects.
Jing S, Liu W, Yang K, Lin Y, et al · · 2023 · cited 2× · PMID 36495036 · DOI 10.1111/cts.13455
Verify or expand the search:
- PubMed search for NCT04161547
- 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 NCT04161547 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Last refreshed: 28 April 2021
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/NCT04161547.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing