A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety, tolerability and pharmacokinetics of NCP 112 after single and multiple
      applications on the skin of healthy male volunteers.
    

Detailed description: 
      Atopic dermatitis is presented as eczematous lesions. Some rashes, discharge, and blisters
      appear at the acute stage and skin lesions of lichenification appear as the skin becomes
      thick and leathery at the chronic stage. If not treated properly, a vicious cycle of
      inflammation of the immune system and further damage to the skin barrier is produced. In
      particular, enhanced immune reaction to external environmental stimuli plays a major role in
      inducing pruritis, an essential feature of atopic dermatitis. Pruritis triggers scratching,
      which in turn leads to an 'itch-scratch-itch' vicious cycle', resulting in secondary skin
      changes. Therefore, it is important to break the vicious cycle, which worsens the symptoms by
      means of an optimal treatment.

      NCP112 is a first-in-class drug candidate, with a novel target strategy for atopic
      dermatitis, different from those of the other currently available drugs; The Investigators
      believe that NCP112 might show a potential as an effective therapy for atopic dermatitis in
      animal models. Since the efficacy and safety have not been fully elucidated, new adverse
      reactions, unidentified from the non-clinical data, could appear later. Provided that NCP112
      effectively alleviates atopic dermatitis, an intractable chronic disease, it is presumed that
      the expected benefits would outweigh the foreseeable risks. In the present trial, safety,
      including occurrences of adverse drug reactions, was thoroughly observed.

      This trial was designed as a single-center, block-randomized, double-blind,
      placebo-controlled, single and multiple dose-ascending trial in which subjects were allocated
      to either topical application of NCP112 or placebo (vehicle).

      The purpose of the present trial was to primarily access the safety of NCP112, the test drug
      of the trial, in healthy male adults prior to administer the test drug to the real patients
      with atopic dermatitis, the proposed indication.
    

Intervention name(s): NCP112
Intervention type(s): Drug
Intervention description(s): The first two subjects for sentinel dosing are randomly assigned to either the test drug or placebo in a 1:1 ratio. After safety and tolerability were reviewed for sentinel participants up to 24 hours after dosing, the subsequent 7 subjects are randomized to the remaining treatment allocations, with 5 subjects to the test drug and 2 to the placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Single-center, Randomized, Double-blinded, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment