The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetics of ATTO-1310 in healthy adults, patients with atopic dermatitis and patients with chronic pruritus. The main questions it aims to answer are: What medical problems do participants have when taking ATTO-1310? How long does ATTO-1310 stay in the body after dosing? Researchers will compare ATTO-1310 to a placebo (a look-alike substance that contains no drug). Participants will be dosed with ATTO-1310 or a placebo, visit the clinic for checkups and tests, and keep a diary of their symptoms.
This is a 4-part study. Parts 1 and 2 will be a single and multiple ascending dose design, respectively, assessing the safety, tolerability and PK of ATTO-1310 in healthy adult volunteers. Part 3 and Part 4 will consist of a single dose in adult patients with atopic dermatitis or chronic pruritus, respectively, to assess safety, tolerability, PK, and PD based on biomarkers in the blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
ATTO-1310 Attobody
Placebo preparation to match ATTO-1310 Dose
Attovia Clinical Site 103
Encinitas, California, United States
Attovia Clinical Site 116
Rocklin, California, United States
Attovia Clinical Site 107
Sacramento, California, United States
Attovia Clinical Site 109
Coral Gables, Florida, United States
Attovia Clinical Site 118
Margate, Florida, United States
Attovia Clinical Site 102
Plainfield, Indiana, United States
Attovia Clinical Site 104
Saint Joseph, Missouri, United States
Attovia Clinical Site 106
Reno, Nevada, United States
Attovia Clinical Site 114
New York, New York, United States
Attovia Clinical Site 119
New York, New York, United States
...and 7 more locations
Incidence of AEs
The primary analysis will describe the incidence of AEs and laboratory abnormalities. AEs will be coded according to system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA, version 26.1 or the current version). Their severity will be graded using the NCI CTCAE v5.0 or the current version.
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Incidence of laboratory abnormalities
Clinical laboratory parameters (hematologic and blood chemistry) will be summarized for each post-baseline visit.
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Incidence of ECG abnormalities
ECG findings (including QT abnormalities) will be summarized for each post-baseline visit.
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Incidence of vital sign abnormalities
Vital signs (systolic and diastolic blood pressure, temperature, heart rate) will be summarized for each post-baseline visit.
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Incidence of Anti-Drug Antibodies
Baseline prevalence of ADA, Changes in ADA status from prior to the first dose of IP to each post-dose timepoint and ADA titer values for samples confirmed positive for ADA will be evaluated to assess the immunogenicity of single and multiple dose levels of ATTO-1310.
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Peak plasma concentration (Cmax) ATTO-1310
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include maximum concentration (Cmax)of ATTO-1310
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Circulating half-life of ATTO-1310 (t1/2)
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include half-life (t1/2) of ATTO-1310
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Area Under the Plasma Concentration Versus Time Curve (AUC)
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include area under the plasma concentration-time curve (AUC).
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Clearance rate (C) of ATTO-1310
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include characterization of the Clearance rate (C) of ATTO-1310
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Volume of Distribution (V) of ATTO-1310
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include characterization of the Volume of distribution (V) of ATTO-1310
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
Bioavailability (F) of ATTO-1310
The pharmacokinetics of single and multiple dose levels of ATTO-1310 in participants will include characterization of the Bioavailability (F) of ATTO-1310
Time frame: 0-113 Days for SAD; 0-143 Days for MAD
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