To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.

NCT07760467 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: TUL-TUL321（I-2）202605
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK

Conditions

Paroxysmal Nocturnal Hemoglobinuria, PNH

Outcome Measures

Primary Outcomes (1)

• 1.Incidence of adverse events (AEs) 2.Changes from baseline in physical examinations, vital signs, electrocardiograms (ECG), and laboratory tests

  up to 17 days

Secondary Outcomes (6)

• Peak plasma concentration (Cmax)

  Pre-dose to 144 hours post-dose

• Time to maximum plasma concentration (Tmax)

  Pre-dose to 144 hours post-dose

• Cumulative amount excreted（Ae）in urine

  Pre-dose to 144 hours post-dose

• Cumulative amount excreted（Ae）in feces

  Pre-dose to 144 hours post-dose

• Alternative pathway (AP) activity

  Pre-dose to 144 hours post-dose

Study Arms (2)

TUL321

EXPERIMENTAL

Healthy participants take oral TUL321 capsules: Part1 single ascending doses, Part2 multiple daily doses to assess safety, tolerability, PK, PD and food effect.

Drug: Part1: TUL321; Drug: Part2: TUL321

Placebo

PLACEBO COMPARATOR

Healthy participants receive oral placebo capsules matching TUL321 capsules in Part 1 and Part 2, administered in parallel with TUL321 treatment cohorts as control.

Drug: Part1: Placebo; Drug: Part2: Placebo

Interventions

Part1: TUL321 DRUG

orally, 20 mg、50 mg、 100 mg、200 mg、400 mg and 600 mg

Also known as: TUL321

TUL321

Part1: Placebo DRUG

Oral placebo capsules matching TUL321 capsules

Also known as: Placebo

Placebo

Part2: TUL321 DRUG

orally, 50 mg QD、100 mg QD、300 mg QD、50 mg BID

Also known as: TUL321

TUL321

Part2: Placebo DRUG

Oral placebo capsules matching TUL321 capsules

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants can communicate well with investigators, fully understand the study, volunteer to take part, comply with all study requirements, and sign written informed consent before study procedures.
• Age 18-45 years (inclusive) at informed consent, male or female.
• Weight ≥50.0 kg for males, ≥45.0 kg for females; BMI 19.0-26.0 kg/m² (inclusive).
• Female participants with child-bearing potential, and male participants whose partners have child-bearing potential: no pregnancy, sperm or egg donation from consent to 3 months after last dose, and willing to use study-required contraception.
• For MAD-only participants: receive ACYW135 meningococcal vaccine and pneumococcal vaccine at least 14 days before first dose. No re-vaccination is needed if pneumococcal vaccine was given within 5 years, or ACYW135 meningococcal vaccine within 3 years prior to first dose.

You may not qualify if:

• Suspected or confirmed allergy to investigational product or its similar components; or history of multiple drug/food allergies.
• Past history of tuberculosis infection or active tuberculosis at screening.
• Known or suspected history of immunodeficiency, inherited or acquired complement deficiency.
• Confirmed active systemic bacterial, viral or fungal infection within 2 weeks before screening.
• History of confirmed encapsulated bacterial infection within 6 months before screening, including but not limited to meningococcus, streptococcus pneumoniae, Haemophilus influenzae type b.
• Clinically significant abnormal findings in laboratory tests, physical examination, vital signs, ECG, chest X-ray or abdominal ultrasound at screening.
• QTcF (Fridericia correction) ≥450 ms at screening; or other risk factors for torsades de pointes (TdP), such as heart failure, hypokalemia, hypomagnesemia, family history of long QT syndrome.
• eGFR \<90 mL/min/1.73 m² (calculated by CKD-EPI formula) at screening.
• Positive for HBsAg, anti-HCV, anti-HIV or syphilis-specific antibody at screening.
• Received other vaccines not specified in the protocol within 1 month before screening, or plan to receive such vaccines during the study.
• Participated in another interventional clinical trial within 3 months before screening (excluding subjects who only completed screening without enrollment, or enrolled but did not receive study treatment).
• Average daily cigarette consumption \>5 cigarettes within 3 months before screening.
• History of drug/substance abuse within 6 months before screening, or positive drug abuse screening test.
• Chronic constipation or diarrhea, or other conditions judged by investigator to interfere with fecal sample collection.
• Required or plan to perform heavy physical labor or strenuous exercise during study participation.

Sponsors & Collaborators

• Zhuhai United Laboratories Co., Ltd.: lead

Study Sites (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Officials

• Guoping Yang

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guoping Yang

CONTACT

+86-13974817168; ygp9880@163.com

Study Design

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

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 26, 2026
• Primary Completion (Estimated): May 8, 2027
• Study Completion (Estimated): May 8, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)