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Phase I single ascending dose study of T-4288 in healthy adult subjects

Phase I single ascending dose study of T-4288 in healthy adult subjects

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222225
Enrollment
Unknown
Registered
2013-09-17
Start date
2013-09-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese healthy adult male subjects

Interventions

investigational material(s) Generic name etc : T-4288 INN of investigational material : Solithromycin Therapeutic category code : 614 Antibiotic preparations acting mainly on gram-positive bacteria an

Sponsors

Toyama Chemical Co., Ltd.(Current FUJIFILM Toyama Chemical Co., Ltd.)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1.Japanese healthy male subjects between 20 and 55 years of age 2.BMI between 18.0 and 30.0 kg/ m2 3.Understand the requirements of the study and voluntarily consent to participate in the study 4.Others

Exclusion criteria

Exclusion criteria: 1.Have a history or presence of clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition, which, in the opinion of the PI, would jeopardize the safety of the subject or impact the validity of the study results 2.Have a history of allergy to macrolide antibiotics 3.Have made a blood donation within 14 days prior to Day 1 dosing 4.Others

Design outcomes

Primary

MeasureTime frame
pharmacokinetic profile, safety and tolerability same as above—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026