A Clinical Study of AK0610

NCT06996704 | Recruiting Phase 1

• 1 other identifier: AK0610-2001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The study consists of two parts: dose escalation and expansion. It includes five cohorts in the dose-escalation phase and two expansion cohorts based on pharmacokinetic data.

Conditions

Healthy Volunteer Study

Keywords

Phase 1 study of AK0610

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Capture the incidence and severity of adverse events using CTCAE v5.0, documenting all treatment-emergent adverse events (TEAEs) throughout the study period.

  Up to 361 days

Secondary Outcomes (11)

• Maximum Observed Serum Concentration (Cmax) of AK0610

  Up to 361 days

• Time to Reach Maximum Observed Serum Concentration (Tmax) of AK0610

  Up to 361 days

• Area Under the serum concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) of AK0610

  Up to 361 days

• Area Under the serum concentration-time curve from time 0 to extrapolated to infinite time (AUC (0-infinity) ) of AK0610

  Up to 361 days

• Terminal Elimination Half Life (t1/2) of AK0610

  Up to 361 days

Study Arms (7)

Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml

EXPERIMENTAL

AK0610 100 mg or Placebo 1 ml，Intramuscular injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml

EXPERIMENTAL

AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml

EXPERIMENTAL

AK0610 300 mg or Placebo 3 ml，Intravenous injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml

EXPERIMENTAL

AK0610 1000 mg or Placebo 10 ml，Intravenous injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml

EXPERIMENTAL

AK0610 3000 mg or Placebo 30 ml，Intravenous injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml

EXPERIMENTAL

AK0610 300 mg or Placebo 3 ml，Intramuscular injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml

EXPERIMENTAL

AK0610 600mg or Placebo 6ml，Intramuscular injection，once on Day 1.

Drug: AK0610 Injection solution; Drug: Placebo

Interventions

AK0610 Injection solution DRUG

Active Substance: AK0610 Pharmaceutical Form: Injection solution Route of Administration: Intramuscular injection or intravenous injection.

Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml; Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml; Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml; Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml; Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml; Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml; Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml

Placebo DRUG

Active Substance: Placebo Pharmaceutical Form: Injection Route of Administration: Intramuscular injection or intravenous injection

Escalation Phase Cohort 1: AK0610 Injection 100 mg or placebo 1 ml; Escalation Phase Cohort 2: AK0610 Injection 300 mg or Placebo 3 ml; Escalation Phase Cohort 3: AK0610 Injection 300 mg or Placebo 3 ml; Escalation Phase Cohort 4: AK0610 Injection 1000 mg or Placebo 10 ml; Escalation Phase Cohort 5: AK0610 Injection 3000 mg or Placebo 30 ml; Expansion Phase Cohort 6: AK0610 Injection 300 mg or Placebo 3 ml; Expansion Phase Cohort 7: AK0610 Injection 600 mg or Placebo 6 ml

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants aged 18 - 50 (both males and females)
• Males weighing ≥50 kg, females weighing ≥45 kg, and BMI 18-28 kg/m2.
• Assessed by the investigator to be in good health with no clinically significant abnormalities.
• Use of highly effective contraception within 1 year of administration.
• Voluntary participation in clinical research and signing of written informed consent.

You may not qualify if:

• Clinically significant cardiovascular, respiratory, hepatic, renal, hematologic (e.g., bleeding disorders), gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric system disorders, or any other condition that, in the opinion of the Investigator, may jeopardize subject safety or validity of the study results, or that may result in the inability of the subject to complete the study in accordance with the protocol.
• Active malignancy and/or a history of malignancy (except for basal cell carcinoma of the skin that has been treated without evidence of recurrence)
• History of congenital or acquired immunodeficiency.
• Acute illness, such as fever, infectious disease, diarrhea, etc., occurring within 1 week prior to the subject's first dose.
• Major surgery within 3 months prior to screening or major surgery planned within 1 year of study drug administration.
• Hypersensitivity to the active ingredient of AK0610 or any excipients.
• Previous history of allergy to biologics or history of severe allergic reaction (e.g. hypotension, dyspnea, severe angioedema) to any drug.
• Human immunodeficiency virus (HIV) antibody positive; hepatitis C virus (HCV) antibody positive or hepatitis B surface antigen (HBsAg) positive; syphilis spirochete antibody positive.
• Systolic blood pressure ≥140 mmHg or \<90 mmHg or diastolic blood pressure ≥90 mmHg or \<60 mmHg, and pulse \<55 or \>100 beats/min.
• ECG suggestive of prolonged QTcF (≥450 ms in both women and men). \[QTcF= QT/(RR\^0.33)\]
• Use of any prescription, over-the-counter, herbal, proprietary, or health care product (other than birth control pills) within 14 days prior to study drug administration.
• Have received treatment with immune globulin or other blood products within 6 months prior to study drug administration
• Have received treatment with monoclonal antibodies or other biological products within 6 months prior to administration of study drug.
• Have received a live attenuated vaccination within 1 month prior to study drug administration, has received another vaccination within 14 days, or is scheduled to receive a vaccination within 1 year of study drug administration.
• Received any other investigational drug therapy within 3 months (or 5 half-lives, whichever is longer) prior to study drug administration, or plans to participate in another study within 1 year of study drug administration.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital ）

Jinan, Shandong, China

RECRUITING

Central Study Contacts

Nina Shen

CONTACT

02150681677; nina.shen@arkbiosciences.com

Study Design

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

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 30, 2025
• Study Start: February 29, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-04

Locations

CN (1)