A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

NCT07152444 | Not Yet Recruiting Phase 1

• 1 other identifier: QSL1410-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of single and multiple ascending doses of QLS1410 in healthy Chinese adults and participants with mild essential hypertension

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0

  up to approximately 1 month

Secondary Outcomes (7)

• Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]

  up to approximately 1 month

• Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]

  up to approximately 1 month

• Maximum observed plasma concentration (Cmax)

  up to approximately 1 month

• Terminal elimination half-life (t1/2)

  up to approximately 1 month

• Apparent clearance (CL/F)

  up to approximately 1 month

Study Arms (2)

QLS1410

EXPERIMENTAL

Part A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg \~ 20 mg) of QLS1410 or placebo,especially, the starting dose will be 0.5 mg of QLs1410 Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part. Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part.

Drug: QLS1410 (CYP11B2 inhibitor)

Placebo

PLACEBO COMPARATOR

Part A: Healthy adults will be randomized (6:2) to receive a single dose (1.5 mg \~ 20 mg) of QLS1410 or placebo Part B: QLS1410 will be administered under the fasted or fed conditions in two different periods separated by a wash-out interval of 14 days. The dose of QLS1410 or placebo is based on upcoming data from SAD part. Part C: Hypertensive participants will be randomized (8:2) to receive QLS1410 or placebo QD for 14 continuous days. The starting dose of QLS1410 or placebo is based on upcoming data from SAD part.

Drug: placebo

Interventions

QLS1410 (CYP11B2 inhibitor) DRUG

QLS1410 tablets

QLS1410

placebo DRUG

Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part A \& Part B: Healthy Participants
• Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
• Males and females aged 18 to 55 years, inclusive.
• Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m\^2, inclusive, at screening.
• Has a mean seated office systolic blood pressure (SBP) 110\~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70\~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
• QTcF (QT corrected using Fridericia's formula) \<450 ms for males and \<470 ms for females.
• Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.
• Part C: Participants with Mild Essential Hypertension
• Able to understand and willing to comply with all study visits, procedures, restrictions and provide the ICF.
• Males and females aged 18 to 65 years (18 to 65 years in MAD study), inclusive.
• Weight ≥ 50 kg for males and ≥ 45 kg for females, BMI between 18 and 28 kg/m\^2, inclusive, at screening.
• Has a mean seated office SBP 140\~159 mmHg (inclusive) and DBP 85\~99 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
• QTcF \<450 ms for males and \<470 ms for females.
• No use of antihypertensive medications (including ACEIs, ARBs, CCBs, ARNIs, diuretics, etc.) within 30 days prior to signing the ICF.
• Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.

You may not qualify if:

• Part A \& Part B: Healthy Participants
• Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
• Use of systemic corticosteroids within 3 months prior to screening.
• Mean pulse/heart rate (HR) \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
• Any laboratory abnormalities that meet the test requirements should be noted during screening (if necessary, retest can be conducted at least one week apart):
• Smoking \>5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
• Alcohol consumption \>14 units/week (1 unit = 360 mL of beer, 45 mL of 40% spirits, or 150 mL of wine) within 6 months before screening, or has a positive breath alcohol test at screening.
• Blood donation \>400 mL within 3 months or \>200 mL within 4 weeks before screening, or plan to donate blood during the study.
• Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
• Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.
• Pregnant/lactating females or positive pregnancy test at screening.
• Inability to tolerate a high-fat meal (for Part B only).
• Part C: Participants with Mild Essential Hypertension
• Secondary hypertension.
• Orthostatic tachycardia or hypotension at screening, or history of related symptoms (e.g., dizziness, weakness, blurred vision upon standing).

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Central Study Contacts

Haiyan Li, B.M

CONTACT

18600489179; haiyanli1027@hotmail.com

Cheng Cui, M.D

CONTACT

13011825605; cuicheng1226@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

CN (1)