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NCT06560593
A Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics Characteristics of NTQ5082 Capsules Orally Administered in Healthy Volunteers in Single and Multiple Doses
Phase 1 trial testing NTQ5082 in Complement-mediated Hemolytic Diseases in 82 participants. Not yet recruiting.
1 December 2024
Quick facts
| Lead sponsor | Nanjing Chia-tai Tianqing Pharmaceutical |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 82 |
| Start date | 1 August 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 February 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- NTQ5082
- Placebo
Conditions studied
- Complement-mediated Hemolytic Diseases — all drugs for Complement-mediated Hemolytic Diseases →
Sponsor
Nanjing Chia-tai Tianqing Pharmaceutical — full company profile →
Who can join
Adults 18 to 45, any sex, with Complement-mediated Hemolytic Diseases. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
the safety and tolerability
Time frame: up to 21 days
Safety and tolerability as assessed through collection of Adverse Event, Serious Adverse Event, Clinical Chemistry/Haematology/Coagulation/Vital Signs and ECG
Sponsor's own description
NTQ5082 capsule is a small molecule CFB factor inhibitor. The study is a randomized, double-blind, placebo-controlled, dose escalation phase 1 clinical trial to evaluate the safety, tolerability and PK/PD characteristics of NTQ5082 capsules orally administered in healthy subjects in single and multiple doses.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06560593
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Nanjing Chia-tai Tianqing Pharmaceutical trials
Trials by the same sponsor.
- NCT07462130 — An Efficacy and Safety Study of NTB003 in Participants With Thyroid Eye Disease (TED) · Phase 1, PHASE2 · not yet recruiting
- NCT07393321 — A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HE · Phase 3 · not yet recruiting
- NCT06977763 — Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection · NA · not yet recruiting
- NCT07182552 — Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics of NTB003 in Healthy Participants · Phase 1 · enrolling by invitation
- NCT06977750 — Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection · NA · 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 NCT06560593 (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 Nanjing Chia-tai Tianqing Pharmaceutical
- Last refreshed: 16 August 2024
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/NCT06560593.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing