Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01952548

Enrollment

Unknown

Registered

2013-09-30

Start date

2013-05-31

Completion date

Unknown

Last updated

2013-12-31

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

Conditions

Safety and Tolerability

Brief summary

This study will test single doses of the study drug in increasing amounts to see if it is safe.

Interventions

DRUGK-312

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Inclusion criteria

* Subject provides written informed consent before any study-specific evaluation is performed. * Subject is a healthy adult male or a female of non-childbearing potential between the ages of 18 and 45 years, inclusive. * Subject has a body mass index of 18.5 to 32 kg/m2, inclusive.

Exclusion criteria

* Subject is a woman who is of childbearing potential or is breastfeeding. * Subject has the presence of an active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment.

Design outcomes

Primary

Measure	Time frame
Adverse Events	10 Days

Countries

United States

Outcome results

None listed

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