NCT06912295 Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants
| NCT ID | NCT06912295 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Yidian Pharmaceutical Technology Development Co., Ltd. |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2025-03-21 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
Eligibility Criteria
Inclusion Criteria: 1. Healthy participants, males and females. 2. Between the ages of 18 and 45 years old (inclusive). 3. Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg/m2 (inclusive). 4. During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance. Exclusion Criteria: 1. Females who are pregnant or breastfeeding; females/males who are prepared for having children. 2. History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data. 3. Active infectious diseases which need anti-infection treatment. 4. Significant surgery within three months and not fully recovered per investigator's judgments. 5. Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc. 6. Immunosuppressive diseases, e.g., immunodeficiency, etc.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06912295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06912295 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06912295 currently recruiting?
Yes, NCT06912295 is actively recruiting participants. Contact the research team at clinical_trial@hllife.com.cn for enrollment information.
Where is the NCT06912295 trial being conducted?
This trial is being conducted at Wuxi, China.
Who is sponsoring the NCT06912295 clinical trial?
NCT06912295 is sponsored by Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.. The trial plans to enroll 76 participants.