Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481597

Enrollment

Registered

2011-11-29

Start date

2011-11-30

Completion date

2012-04-30

Last updated

2012-05-16

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

Conditions

Healthy

Keywords

deuteporfin, safety, tolerability, pharmacokinetics, healthy volunteers

Brief summary

Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.

Interventions

DRUGdeuteporfin

deuteporfin 1 mg/kg IV as a single dose

DRUGplacebo

Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Chinese healthy male and/or female subjects * 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2 * weigh at least 45 kg for female subjects or 50 kg for male subjects * In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

* Significant illness or major surgery within four weeks prior to dosing * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy) * Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing * Participation in any clinical investigation within 30 days prior to dosing * Smokers, alcoholics, drug abusers * Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result * pregnancy or lactation for female subjects

Design outcomes

Primary

Measure	Time frame	Description
number of participants with adverse events	up to 19 days following injection	number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects

Secondary

Measure	Time frame	Description
Pharmacokinetic profile	predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose	Pharmacokinetic profile: Cmax (Peak Concentration), AUC (area under the plasma-concentration-time curve ), T1/2 (half life)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026