A Phase 1 Study of ISM4808 in Healthy Adult Subjects

NCT07415304 | Not Yet Recruiting Phase 1

• 1 other identifier: ISM4808-101
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  A TEAE is an adverse event (AE) occurrence in a subject who received study drug whether or not considered related to the study product. Any adverse event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment is categorized as SAE. The number of participants who experience at least one TEAE and SAE will be presented.

  SAD/food-effect cohorts: From first dose up to Day 9; MAD cohorts: From first dose up to Day 18

Secondary Outcomes (11)

• Terminal elimination half-life (t1/2) of ISM4808

  SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose

• Terminal elimination half-life (t1/2) of ISM4808

  MAD cohorts: Day 1 and Day 10

• Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808

  SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose

• Time to Maximum Observed Plasma Concentration (Tmax) of ISM4808

  MAD cohorts: Day 1 and Day 10

• Maximum Observed Plasma Concentration (Cmax) of ISM4808

  SAD/Food-effect cohorts: Pre-dose through 72 hours post-dose

Other Outcomes (4)

• Maximum Observed Serum Concentration (Cmax) of Erythropoietin (EPO)

  SAD cohorts: From Day 1 pre-dose through 72 hours post-dose; MAD cohorts: Day 1 and Day 10

• Time to Maximum Observed Serum Concentration (Tmax) of EPO

  SAD cohorts: From Day 1 pre-dose through 72 hours post-dose ; MAD cohorts: Day 1 pre-dose, Day 1 and Day 10

• Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of EPO

  SAD cohorts: Pre-dose through 72 hours post-dose ; MAD cohorts: Day 1 and Day 10

Study Arms (2)

ISM4808

EXPERIMENTAL

Participants receive ISM4808 administered orally in single ascending dose and multiple ascending dose regimens.

Drug: ISM4808

Placebo

PLACEBO COMPARATOR

Participants receive matching placebo administered orally in single ascending dose and multiple ascending dose regimens.

Drug: Placebo

Interventions

ISM4808 DRUG

ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data.

ISM4808

Placebo DRUG

Matching placebo administered orally under the same conditions as ISM4808.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide written informed consent and comply with all study procedures.
• Healthy male or female adults aged 18 to 55 years at the time of informed consent.
• Body mass index (BMI) 19-26 kg/m²; body weight ≥50 kg (males) and ≥45 kg (females).
• Medically healthy with no clinically significant abnormalities in medical history, physical examination, vital signs, laboratory tests, or 12-lead ECG, as determined by the investigator.
• Women of childbearing potential and male subjects with partners of childbearing potential must agree to use effective contraception from screening through 3 months after the last dose of investigational product.

You may not qualify if:

• History or presence of any clinically significant disease (including cardiovascular, neurological, psychiatric, gastrointestinal, hepatic, renal, hematologic, endocrine, or immune disorders) that may interfere with study participation or data interpretation.
• Personal or family history of clinically significant cardiac disease, including QT prolongation, torsades de pointes, myocardial infarction, heart failure, or sudden cardiac death.
• Use of medications known to prolong QT/QTc interval or treatment for clinically significant cardiac conditions.
• Screening 12-lead ECG abnormalities, including QTcF \>450 ms (males) or \>470 ms (females), PR interval \>210 ms, QRS duration \>110 ms, clinically significant arrhythmias, or uncontrolled hypertension.
• Participation in another interventional clinical trial or receipt of any investigational drug within 3 months prior to first dosing.
• Blood donation or significant blood loss (≥400 mL) within 3 months prior to first dosing.
• Pregnant or breastfeeding women, or positive pregnancy test at screening or prior to dosing.
• Positive tests for HBsAg, HCV antibody, HIV antibody, or syphilis.
• History of drug or alcohol abuse, positive drug screen, or inability to abstain from alcohol, nicotine, or prohibited substances during the study.
• Use of prescription or non-prescription medications, herbal products, supplements, or vaccines within 28 days prior to dosing, unless approved by the investigator.
• Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

Sponsors & Collaborators

• TaiGen Biotechnology Co., Ltd.: lead
• R&G Pharma Studies Co.,Ltd.: collaborator

Study Officials

• Gan Zhou

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Wen Chang

CONTACT

+886-2-8177-7020 227; lwchang@taigenbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study in which participants and investigators are blinded to treatment assignment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to receive ISM4808 or placebo in parallel cohorts within single ascending dose (SAD) and multiple ascending dose (MAD) phases. A food effect (FE) assessment will be conducted in a selected dose cohort following an appropriate washout period using the same subjects in the single ascending dose cohorts.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 17, 2026
• Study Start: February 13, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02